EyePoint Pharmaceuticals, Inc. (Nasdaq: EYPT), a company committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases, announced that the independent Data Safety Monitoring Committee (DSMC) completed its second scheduled review of the Company’s ongoing pivotal Phase 3 program evaluating DURAVYU for the treatment of wet age-related macular degeneration (wet AMD).
As of the September 29, 2025 data cutoff for the DSMC review, all patients across the LUGANO and LUCIA trials reached the Week 8 visit during which patients in the DURAVYU arms received their initial DURAVYU dose, and approximately 25% of those patients received their second planned dose of DURAVYU at Week 32.
The DSMC recommended that both the LUGANO and LUCIA trials continue as planned, with no modifications to the protocol. The DSMC is an independent panel of experts in ophthalmology and biostatistics who are responsible for reviewing safety data to ensure the welfare of trial participants and to provide recommendations regarding trial conduct. DSMC meetings are scheduled to occur every six months per the trial protocol.
We are pleased to receive our second consecutive positive recommendation from the DSMC for our pivotal wet AMD program. Now that all patients are past initial dosing and a growing number have received redosing, this recommendation strengthens our confidence in DURAVYU’s consistent, favorable safety profile observed across its robust development history. As we advance toward topline data starting in mid-2026, we remain focused on continued clinical trial execution and regulatory preparedness to support our ultimate goal of delivering DURAVYU to patients as expeditiously as possible.
said Ramiro Ribeiro, M.D., Ph.D., Chief Medical Officer at EyePoint.
LUGANO and LUCIA are randomized, double-masked, aflibercept controlled, non-inferiority Phase 3 trials assessing the efficacy and safety of DURAVYU in patients with active wet AMD including both treatment naïve and treatment experienced patients. Enrollment is complete in both trials with over 900 patients enrolled. At Day 1, patients are randomized 1:1 to receive either DURAVYU 2.7mg every six months or aflibercept on-label as control.
The LUGANO and LUCIA trials are the only sustained release wet AMD pivotal Phase 3 trials evaluating 6-month redosing in both trials over two years. DURAVYU is delivered via a standard intravitreal injection in the physician's office, similar to current practice with FDA approved anti-VEGF treatments. The primary endpoint of the Phase 3 pivotal trials is non-inferiority in the average change in best corrected visual acuity (BCVA) at weeks 52 and 56 compared to baseline.
Secondary endpoints include safety, reduction in treatment burden, percentage of eyes free of supplemental aflibercept injections, and anatomical results as measured by optical coherence tomography (OCT). More information about the trial is available at www.clinicaltrials.gov (LUGANO identifier: NCT06668064; LUCIA identifier: NCT06683742).
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